FDA Adverse Event
Other
Summary report: N
OLM INTERCRANIAL PRESSURE MONITOR
MDR report key: 14492
·
Received June 15, 1994
Report
- Report Number
- 14492
- Event Type
- Other
- Date Received
- June 15, 1994
- Date of Event
- June 3, 1994
- Report Date
- June 14, 1994
- Manufacturer
- CAMINO LABORATORIES
- Product Code
- HCA
- Report Source
- User Facility report
- Reporter Location
- OK, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
INTERCRANIAL PRESSURE CATHETER WAS PLACED FOLLOWING SURGERY FOR A RUPTURED ANEURYSM ON 5/31/94. UNIT FUNCTIONED PROPERLY UNTIL 12:30 AM, 6/3/94. NURSES STATE THAT UNIT DISPLAYED "CHECK CONNECTORS" AND HAD NO CHANGES IN VITAL SIGNS. THE ICP CATHETER WAS REMOVED AT 8:00 PM AND REPLACED AT 12:00 PM, 6/3/94. PT EXPIRED AT 9:50 AM, 6/4/94.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLM INTERCRANIAL PRESSURE MONITOR Implant | INTERCRANIAL PRESSURE MONITOR | HCA | CAMINO LABORATORIES | 110-46 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other | PULSE OX| NIBP| ECG| N G SUCTION| IV PUMP, ECG, |